October 21st:Boston Scientific Recognized as Leader in Development of
Rigorous Clinical Trials
Boston Scientific Corporation was recognized by physicians as a leader in
the pursuit of evidence-based medicine through increased use of randomized
controlled clinical trials. The comments were made during the annual
Transcatheter Cardiovascular Therapeutics symposium, in Washington, D.C. The
clinical program supporting the Company's TAXUS® Express2(TM) paclitaxel-
eluting coronary stent system was cited as the type of definitive medical
evidence that physicians should use in making treatment decisions.
Experts Detail How Image-Guided Radiotherapy Technologies from Varian
Medical Systems Enhance the Precision of Cancer Treatment
Cancer treatment
specialists reported yesterday that advanced imaging technologies from
Varian Medical Systems (are helping them target tumors more accurately than
ever before, in order to maximize chances of tumor control while protecting
the surrounding healthy tissues.
Four experts from
leading cancer centers around the world detailed how Varian's On-Board
Imager(TM) device for image-guided radiotherapy is helping them adapt
treatments for tumor motion, efficiently improve treatment precision, and
establish new standards of care. One speaker provided insight into the
future, offering a vision of radiotherapy technology that can detect and
follow tumor motion in real time during treatment.
October 20th:
St. Jude Device Effective In Treating Strokes
A recent clinical trial shows that a St. Jude device is effective in
treating a condition associated with thousands of strokes annually. The
study included 67 patients at five research sites in Europe.
The trial showed that St. Jude's PFO (patent foramen ovale) CLOSE UP
(Closure Using Premere) device was able to close 87 percent of PFOs after
six months without adverse events. PFOs are common defects where a small
hole between the upper chambers of the heart can allow unfiltered venous
blood to enter the arterial circulation. If that blood contains a clot or
other debris, it can cause a stroke. That condition is associated with
200,000 strokes annually, the company said.
Medtronic Heart Stent Lags Rival in Key Trial
Medtronic Inc. said
Monday its drug-coated stent fell slightly behind a chief rival in one key
measure during clinical trials, but overall performance was good and U.S.
sales could begin in 2007.
The stent is the most promising product of the Minneapolis company's
vascular division, which is headquartered in Santa Rosa, officials said.
Medtronic began selling its Endeavor drug-coated stent in Europe in August
and is undertaking four clinical trials in preparation for seeking U.S. Food
and Drug Administration approval to sell the stent in the United States.
The just-completed third trial showed that heart arteries shrank slightly
more with Endeavor than with Johnson & Johnson's Cypher stent eight months
after surgery. Shrinkage is one way to predict whether an artery will
reclog.
But the trial also showed consistently positive outcomes for patients and
ease of delivery for physicians.
Labeling Content
Submissions to Be Put In SPL Format
Beginning at the end of the month, the FDA will require drugmakers to adopt
the structured product language (SPL) format for certain human drug labeling
submissions, according to an
agency official.
On Oct. 31, the FDA will implement its new electronic labeling information
processing system (ELIPS), which cannot read labeling submissions in the
traditional PDF format, Randy Levin, director of health and regulatory data
standards, told FDAnews. ELIPS will automatically retrieve electronic SPL
labeling content for new drug applications abbreviated new drug applications
and biological licensing applications from the agency's electronic document
room and make them available to reviewers, he said.
The agency originally established a late-2004 deadline for drugmakers to
convert submissions to SPL, but the target date was postponed several times
to allow drugmakers to prepare for the switch and to allow various FDA
technology initiatives to be completed.
October 19th:
St. Jude Agrees To Acquire Advanced Neuromodulation Systems for $1.3
Billion
Looking to expand into the underpenetrated neuromodulation market, St.
Jude Medical has signed a definitive agreement to purchase Advanced
Neuromodulation Systems (ANS) for approximately $1.3 billion.
ANS is a technology leader in the estimated $1 billion neuromodulation
medical device market and holds a strong No. 2 market share position in the
spinal cord stimulation segment, St. Jude said. Neuromodulation is the
delivery of very small, precise doses of electricity or drugs directly to
nerve sites and is aimed at treating patients suffering from chronic pain or
other disabling nervous system disorders.
ANS also has clinical trials underway for new indications to address the
expanding markets for Parkinson's disease and essential tremor. The
neuromodulation market has experienced growth of over 20 percent during the
last several years, with continued robust growth expected.
FDA Tells Doctors to Stop Using Boston Scientific's Enteryx
The FDA is warning physicians to immediately stop using Boston
Scientific's injectable polymer Enteryx, which is used to treat
gastroesophageal reflux disease, because of the risk of serious adverse
events including death.
In an Oct. 14 "Dear Healthcare Practitioner" letter, the FDA said the
serious adverse events associated with Enteryx involve unrecognized
transmural injections of the product into structures surrounding the
esophagus. The Enteryx procedure involves injecting a patented liquid
polymer into the lower esophageal sphincter that solidifies into a
sponge-like permanent implant.
Transmural injections can potentially result in death or serious injury,
the FDA said. Signs and symptoms of transmural injection may include chest
pain, flu-like symptoms and pneumonia. Some cases of transmural injection
were not recognized at the time of the procedure or during immediate
follow-up, the agency said. "At this time, it is not possible to provide
accurate estimates of the number of adverse events associated with
transmural injection of Enteryx, or to describe all of the possible
outcomes," the FDA said.
Boston Scientific recently issued a recall of all Enteryx Procedure Kits
and Enteryx Injector Single Packs from commercial distribution. The company
cited "adverse events" resulting from growing reports of incidents that
indicate some physicians are experiencing procedural difficulties with the
device as the reason for the recall.
October 18th:
Abbott Issues Urgent Device Correction
Abbott Diabetes Care has voluntarily initiated a correction and
notification for its blood glucose meters in the U.S. after receiving
consumer complaints that while setting the time and date for the devices,
they have inadvertently changed the units of measure from milligrams per
deciliter to millimoles per liter.
This change could lead to misinterpretation of test results, which could
result in possible under-treatment and the potential for hyperglycemia, the
company said. Abbott is advising users to make sure the device is displaying
the correct unit of measure each time they test. The company is working with
the FDA to execute this voluntary correction.
The products are sold under several model names in the U.S., including
FreeStyle, FreeStyle Flash, FreeStyle Tracker, Precision Xtra, MediSense
Sof-Tact, and MediSense Optium. Private label brands include ReliOn Ultima,
Rite Aid and Kroger blood glucose meters. Test strips are not affected by
this correction.
Evalve Launches Pivotal Trial of Percutaneous Alternative to Open-Heart
Mitral Valve Surgery
Evalve has initiated a pivotal study to demonstrate the safety and
efficacy of its MitraClip percutaneous valve repair system for patients with
mitral regurgitation (MR).
The Endovascular Valve Edge-to-Edge REpair STudy (EVEREST) II trial is a
randomized, multicenter study comparing the MitraClip technique to standard
surgical mitral valve repair or replacement in patients with functional or
degenerative MR. Approximately 30 medical centers across North America will
be participating in the study.
To qualify for the EVEREST II trial, patients must have a weakened left
ventricle, or have moderate-to-severe MR and be experiencing symptoms
(fatigue, chest pain, or shortness of breath).
During the procedure, a catheter is introduced through the patient's skin
in the groin area and is then guided through the femoral vein into the
affected area of the heart. A smaller delivery catheter that holds the
MitraClip is then introduced through this tube so that the clip can be
guided into place and attached to the leaflets (the "swinging doors") of the
mitral valve. Once the clip is securely attached, it is deployed and the
catheters are removed.
Positive Trial Results Reported For Cancer Vaccine
Biotechnology firm Antigenics is preparing to launch a pivotal trial for
its cancer vaccine Oncophage — a move that comes in the wake of preliminary
data from a late-stage clinical trial that showed the drug extended the
survival of advanced skin cancer patients.
Antigenic's decision to move forward with the pivotal trial stems from early
results from a Phase III study that showed Stage IV skin cancer patients
treated with Oncophage lived an average of 20.9 months compared to an
average 12.8 months for patients given standard treatment. The average
survival rate for patients with Stage IV skin cancer is approximately seven
months. In light of the results, Antigenics plans to begin a pivotal Phase
III trial for Oncophage within "several months," CEO Garo Armen said. The
trial will focus on patients with Stage IV M1a advanced melanoma.
Oncophage could represent a breakthrough in cancer treatment, as it is
personalized vaccine made from patients' tumors. The vaccine is designed to
capture the particular cancer's "fingerprint," which contains unique
antigens that are present only in that particular patient's specific cancer
cells. Injection of the vaccine is intended to stimulate the patient's
immune system to recognize and attack cells bearing the specific cancer
fingerprint.
October 17th:
FDA Reports More Instances of ICD Failure
The FDA recently updated its health warning for two of Guidant's
implantable cardioverter defibrillator (ICD) devices because six additional
product failures have occurred since the last warning.
The agency announced recently that there have been six failures of
Guidant's Prizm 2 and Contak Renewal ICDs since the FDA originally issued
warnings on July 14. As of Oct. 7, these failures bring the worldwide total
for the devices to 21 clinical failures and three deaths, the agency said.
"You should take these failures into account as you continue to follow the
patients who retain either device," the FDA noted.
The agency recently approved a modification to the two devices that would
reduce the likelihood of failures in newer devices. The modification
involved replacing the insulating material on the feedthrough wires with a
different insulating material that has better degradation properties.
Boston Scientific Offers Stent Assurance Program
Boston Scientific recently introduced a new program providing
participating U.S. medical centers a Taxus Express2 stent system at no
additional charge if a patient requires re-intervention due to in-stent
restenosis of a previously implanted Taxus Express2 stent. The program will
run from Jan. 1 to Dec. 31, 2006.
To be eligible for participation in the program, a medical center must
enroll in advance through their Boston Scientific sales representative. The
offer applies if a patient with the stent returns to the medical center
within 12 months of implantation because of restenosis.
"The Taxus Stent Assurance Program is our way of saying that we stand
squarely and confidently behind our product," said Hank Kucheman, president
of the company's interventional cardiology business.
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